CIS Survey Reveals Extent of Pharmaceutical Company Internal Audit Coverage
Krzeminski identifies potential risks of not forming and implementing an auditing and monitoring plan.
- Philadelphia, PA-NJ (1888PressRelease) July 16, 2011 - Compliance Implementation Services (CIS), a leading pharmaceutical compliance consulting firm, today announced that during a recent CIS webinar, clients who represent clinical, manufacturing and commercial divisions within pharma were asked about current audit plan trends and their responses indicated that 21% have an annually updated 3 year audit plan, 54% have an audit plan for the current year and 25% do not have an audit plan in place.
"By not developing and implementing an auditing and monitoring plan, pharmaceutical companies could face an increased risk of non-compliance with regulatory requirements, penalties and damage to the brand in the long run," said Tim Krzeminski, Director of Project Management and Audit Services at CIS. "Establishing an ongoing auditing and monitoring program can help companies to mitigate key risks and prioritize audits/assessments by forming an annual or two to three year audit plan. The benefits of creating a robust audit program allow companies to gain better efficiency and maximize resources while ensuring adequate risk coverage throughout the organization to help in establishing a culture of compliance."
Among audit trends discussed during the webinar, Krzeminski noted there has been an increased shift to outsourcing and as a result, vendor audits across all areas of organizations are becoming very common. His article "Don't Get Burned", which can be found in the June edition of Internal Auditor, elaborates that as organizations transition many operations to third-party vendors, internal auditors need to examine the increased risks throughout the process. Krzeminski also presented "On-going Auditing and Monitoring MCO/PBM Vendor Audits" at a recent managed care conference, in which he identified key objectives of an MCO/PBM audit performed on behalf of a pharmaceutical manufacturer including assessing contract compliance, rebate processing, and formulary adherence and reviewed case studies about specific MCO/PBM claims validations and PBM audits.
CIS will provide additional webinars on specific audit topics throughout the year. A complete list of upcoming webinars may be found on CIS's website. In addition to webinars, Krzeminski will also speak on the topic, "Expanding Beyond the Traditional Audit Plan" at a local pharmaceuticial/biotech manufacturer medical device internal audit conference on September 19th and 20th.
About CIS
Compliance Implementation Services (CIS) is a consulting firm specializing in compliance strategies for the pharmaceutical industry, from Global Clinical Research and Development, through Manufacturing, U.S. Commercial Compliance, and Government Programs. Founded in 2004, CIS provides its clients with a deep understanding of industry laws and regulations, innovative and practical applications, and custom solutions to establish a "Culture of Compliance" that is both meaningful and sustainable.
CIS experts identify, assess and prioritize an organization's exposure to compliance risks, subsequently developing and implementing risk evaluation and mitigation techniques to ensure adherence to legal and regulatory requirements.
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